Sensor Validation Study - Quality Assurance

Completed

• Conditions: Respiratory Rate

• Registration Number: NCT03306537
• Lead Sponsor: PMD Solutions

Brief Summary

The respiratory rate is an important parameter in clinical medicine. It is defined as the number of breaths per minute. Currently this is measured at the bedside in clinical practice by counting the breaths, however the gold standard for measuring this vital sign is the capnograph. For the patient, this involves wearing a tube in their nose and around their ears while trying to minimise their movement and talking so that the measurements can be taken.

A new respiratory rate monitor, RespiraSense, is non-invasive and measures the respiratory rate by measuring the displacement between the ribs and abdomen. This research study is intended to validate that this technology is effective and accurate on people with a bigger body mass.

Subjects with a BMI \> 35 will be invited to participate should they meet all of the eligibility criteria. If patients agree to participate, following informed consent, subjects will be monitored for one hour with both the capnograph and RespiraSense measuring at the same time so their results can be compared

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-28
• Study First Submitted: 2017-09-29
• Study First Submitted QC: 2017-10-10
• Study First Posted: 2017-10-11
• Primary Completion: 2018-08-07
• Study Completion: 2018-09-07
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-19
• Last Update Posted: 2019-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• ≥ 18 Years

• Have a BMI ≥35

  • For the sub-group analysis at least 5 subjects with a BMI 35-49 and at least 5 BMI > 50 will be needed

• Are willing to voluntarily sign a statement of informed consent to participate in this investigation

Exclusion Criteria

• Allergic to medical grade skin adhesive
• Continuous oral long term steroid use. To be free from oral steroid use this is defined as not using oral steroids in the 4 weeks previous to enrolment
• Patients under the influence of substance abuse (drug or alcohol) that may interfere with their ability to cooperate and comply with the investigation procedures
• Any disorder, including cognitive dysfunction, which would affect the ability to accurately complete questionnaires and freely give full informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of PMD RespiraSense against capnography in obese patients.	1 hour	Analysed using a Bland Altman (BA) analysis to measure limits of agreement between both methods. The BA analysis will correct for repeated measures within each subject if required. In addition, a Deming Regression will be performed on the collected data.

Secondary Outcome Measures

Name	Time	Method
Comparison of PMD RespiraSense in obese patients with BMI below 50 and those with BMI of 50 or above.	1 hour	Analysed using a Bland Altman (BA) analysis to measure limits of agreement between both methods. The BA analysis will correct for repeated measures within each subject if required. In addition, a Deming Regression will be performed on the collected data.
Collection of feedback on device comfort when worn by patients with high BMI.	1 hour	Will not be analysed formally.
Identification of any accuracy spread patterns as BMI increases.	1 hour	Analysed using a Bland Altman (BA) analysis to measure limits of agreement between both methods. The BA analysis will correct for repeated measures within each subject if required. In addition, a Deming Regression will be performed on the collected data.

Trial Locations

Locations (1)

Queen Alexandra Hospital; 🇬🇧 Portsmouth, United Kingdom